Study Comparing Metformin and Tolvaptan for Adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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What is this study about?

This clinical trial is focused on studying a condition called Autosomal Dominant Polycystic Kidney Disease (ADPKD). This is a genetic disorder that causes numerous cysts to grow in the kidneys, which can lead to kidney failure over time. The study is comparing two treatments: Metformin and Tolvaptan. Metformin is commonly used to treat diabetes, but researchers are exploring its potential benefits for ADPKD. Tolvaptan is a medication specifically used to slow down the progression of kidney disease in ADPKD patients.

The purpose of the study is to determine if taking 1500 mg of Metformin daily for two years is as effective or not inferior to Tolvaptan in slowing down the decline of kidney function in people with ADPKD. Participants in the study will be randomly assigned to receive either Metformin or Tolvaptan. The study will last for two years, during which participants will have regular check-ups to monitor their kidney function and overall health.

Throughout the study, the main focus will be on measuring the change in kidney function, specifically looking at the estimated glomerular filtration rate (eGFR), which is a test used to check how well the kidneys are working. Additionally, the study will assess changes in the size of the kidneys using a CT-scan at 12 and 24 months. This research aims to provide valuable insights into the effectiveness of Metformin compared to Tolvaptan in managing ADPKD.

1 randomization

Upon joining the study, participants are randomly assigned to one of two groups. One group will receive metformin, and the other will receive tolvaptan.

This process ensures that each participant has an equal chance of being assigned to either treatment group.

2 medication administration

Participants in the metformin group will take 1500 mg per day. This medication is administered orally in tablet form.

Participants in the tolvaptan group will take the medication in tablet form as well. The specific dosage will be either 15 mg + 45 mg, 30 mg + 60 mg, or 30 mg + 90 mg, depending on the assigned regimen.

Both medications are taken daily for the duration of the study.

3 monitoring and assessments

Participants will undergo regular monitoring to assess kidney function. This includes measuring the estimated glomerular filtration rate (eGFR), which indicates how well the kidneys are filtering.

The primary outcome is to evaluate the difference in the annualized slope of eGFR between the two treatment groups.

Secondary assessments include measuring the percent change in total kidney volume (htTKV) using a CT scan at 12 and 24 months.

4 study duration

The study is conducted over a period of two years.

Participants will continue their assigned treatment and attend scheduled assessments throughout this time.

5 completion

At the end of the study period, final assessments will be conducted to evaluate the outcomes of the treatments.

The study aims to determine if metformin is equivalent or not inferior to tolvaptan in reducing the decline of kidney function in participants with Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Who Can Join the Study?

Men and women aged between 18 and 55 years
A certain level of kidney function, measured as a mean of eGFR (a test that shows how well your kidneys are working) of at least 45 ml/min/1.73 m² in two specific visits
A Genetic Diagnosis of Type I ADPKD with a specific kind of mutation called a truncating mutation
Signed and dated informed consent, which means you agree to participate in the study after being told all the important details

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Universita’ Degli Studi Di Modena E Reggio Emilia	Modena	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Ozopzwws Snm Bpfhlyo dr Vmdcgnm	Vicenza	Italy
Aykwrxv okjasuaovta uacdbncinlufb -tuvdhqxtfx dzkul Sublp dsgtz Cesoqvvx Lelms Vlmkwfqswv	Naples	Italy
Axoqvo Gfkpjrn Mjplyei	Messina	Italy
Aoeqnkb do Rztamza Ngrgkplgb er Axhd Silonvarqhyfhqui &xbzjfx Ajxsa “sk Bfbikyk (pddpw	Cagliari	Italy
Aa Ov Ug Pluiwwnquhg Gl Rsyrjkylwgbc Mbmzy &qcpbmc Ptuunusb Oflkaqmspxf Sah Mqlpv	Catania	Italy
Ahdwkcy Uxmyv Soixiqulc Ltcwic Dl Bzrafdm	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.04.2021

Trial locations

Investigated drugs:

Metformin is a medication commonly used to manage blood sugar levels in people with type 2 diabetes. In this trial, it is being tested to see if it can help slow down the decline of kidney function in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Tolvaptan is a medication that helps to slow the growth of kidney cysts and preserve kidney function in patients with ADPKD. It works by blocking a hormone that causes the kidneys to retain water, which can help reduce the size of the cysts.

Autosomal Dominant Polycystic Kidney Disease – This is a genetic disorder characterized by the growth of numerous cysts in the kidneys. These cysts are filled with fluid and can lead to an increase in kidney size and a decrease in kidney function over time. As the disease progresses, the cysts can cause the kidneys to become enlarged and may lead to complications such as high blood pressure and kidney stones. The condition is inherited in an autosomal dominant pattern, meaning only one copy of the altered gene is sufficient to cause the disorder. Symptoms often appear in adulthood, and the severity can vary widely among individuals. The disease primarily affects the kidneys, but it can also impact other organs, including the liver and pancreas.

Trial ID:

2024-517864-49-01

Protocol code:

AIFA-2016-02365060

NCT ID:

NCT03764605

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Metformin and Tolvaptan for Adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD)

What is this study about?

Who Can Join the Study?

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